MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Model Number 175806N

Device Problem Burst Container or Vessel (1074)

Patient Problem Irritability (2421)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the silicone catheter placed and balloon inflated to 2 ml.The patient felt irritable intermittently for next two hours and no urine collected in catheter tubing.It was further stated that the balloon attempted to be deflated, but only drops came out.After the patient finished voiding, silicone catheter removed and balloon found to be blown.Per follow up with customer via mail on (b)(6) 2021, there was no adverse event noted, except that a new catheter had to be inserted.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.The device had not met specification as the reported failure was able to be reproduced.The product was used for treatment.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted balloon burst down the entire length of the balloon.This was out of specification per inspection procedure, which states, ¿catheter must not be stretched, wrinkled or deformed." a potential root cause for this failure could be high modulus silicone.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.1.Open the product using standard hospital technique for handling sterile product.2.The catheter may be lubricated with standard water soluble lubricant, to facilitate insertion.3.Insert the catheter following preferred aseptic technique.4.Once the catheter is correctly seated in the bladder, inflate the catheter with 1.5 ml of sterile water.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, reseat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the silicone catheter placed and balloon inflated to 2 ml.The patient felt irritable intermittently for next two hours and no urine collected in catheter tubing.It was further stated that the balloon attempted to be deflated, but only drops came out.After the patient finished voiding, silicone catheter removed and balloon found to be blown.Per follow up with customer via mail on (b)(6) 2021, there was no adverse event noted, except that a new catheter had to be inserted.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11862960
• MDR Text Key: 251927526
• Report Number: 1018233-2021-02956
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034268
• UDI-Public: (01)00801741034268
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 175806N
• Device Catalogue Number: 175806N
• Device Lot Number: NGEU2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other